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Bristol Myers’ Reblozyl Fails Phase III in Myelofibrosis Anemia
Bristol Myers Squibb announced failure of Reblozyl to meet the primary endpoint in the Phase III INDEPENDENCE trial for anemia associated with myelofibrosis, showing no significant reduction in...
GenesisM Breaks Ground on Biomanufacturing Facility in Boston
GenesisM, a joint venture between Bain Capital Real Estate and Botanic Properties, has commenced construction of a 154,000-square-foot Class A biomanufacturing facility in Bedford, Massachusetts....
Thermo Fisher to Acquire Sanofi’s Sterile Manufacturing Site
Thermo Fisher Scientific has agreed to acquire Sanofi’s sterile fill-finish and packaging facility in Ridgefield, New Jersey, enhancing Thermo Fisher’s U.S. manufacturing footprint. The site’s...
AI Advances Undruggable Protein Targeting: Nobel Laureate Baker’s Lab
Researchers from David Baker’s laboratory have developed AI techniques to design protein binders targeting intrinsically disordered regions (IDRs) of proteins, long considered undruggable due to...
Medical University of Vienna Secures €2.5M Grant for Multiomic Biomarker Research
The Medical University of Vienna’s Organizational Unit Core Facilities received €2.5 million from the Austrian Research Promotion Agency to advance multiomics-driven biomarker discovery and...
Funding Trends Show Seed and Series A Up in First Half 2025
Capital flows into early-stage biotech startups have increased in the first half of 2025, with seed and Series A rounds rising to a total of $4.7 billion. However, fewer companies contributed to...
Innovations in Lipid Nanoparticles Enhance mRNA Therapeutic Profiles
A University of Pennsylvania team has demonstrated that modifying the ionizable lipid component of lipid nanoparticles (LNPs) by adding phenol groups can both reduce inflammatory side effects and...
Sarepta gene therapy under FDA scrutiny: third patient death reported
Sarepta Therapeutics is facing intensified regulatory and commercial challenges following the confirmation of a third patient death related to its gene therapy products. The newest fatality...
FDA advisory setbacks for GSK and Otsuka drug approvals
Recent FDA advisory committee meetings have dealt significant blows to GSK and Otsuka’s drug approval plans. GSK’s attempt to reintroduce its multiple myeloma antibody-drug conjugate Blenrep in...
Scipher Medicine expands from rheumatoid arthritis diagnostics to precision immunology
Scipher Medicine, recently under new leadership, is transitioning beyond its commercial molecular assay for rheumatoid arthritis to broader personalized medicine applications across non-oncology...
FDA approvals and clinical updates signal activity in oncology, HIV, weight-loss, and inflammatory diseases
The FDA’s June approvals included 22 drugs, equaling the March total and pushing 2025 into the third-highest year on record for new drug approvals at midyear. Notable approvals include Gilead’s...
Biopharma financing trends and capital flows show mixed dynamics in 2025
The first half of 2025 witnessed a rise in seed and Series A funding in the biotech space, although the number of companies participating declined, reflecting concentrated investment. A prominent...
AI and computational innovations accelerate biotech and drug discovery
Artificial intelligence is increasingly reshaping biotech research and healthcare. New AI models have enabled advances in traditionally undruggable targets such as intrinsically disordered...
Ongoing safety and efficacy challenges for other pharmaceuticals
Several pharmaceutical programs face setbacks impacting clinical and regulatory outlooks. Bristol Myers Squibb’s anemia drug Reblozyl failed its Phase 3 trial in myelofibrosis-associated anemia,...
MedTech IPOs and manufacturing expansions reflect sector momentum
Heartflow Inc. recently submitted its S-1 filing to the SEC, adding to a growing list of medtech companies pursuing public offerings in 2025, signaling robust investor interest in the sector....
Regulatory and reimbursement shifts impact molecular diagnostics and transplant monitoring
MolDx program’s proposed local coverage determination (LCD) would restrict the frequency of molecular surveillance testing for transplant rejection, setting limits substantially below current...
Hormone therapy for menopause faces regulatory reconsideration
An FDA convened panel of medical experts urged the removal of black box warnings on menopausal hormone therapy (MHT), citing benefits outweighing risks in symptomatic relief and potential...
Sarepta Gene Therapy Faces Safety Scrutiny – Third Patient Death Reported
Sarepta Therapeutics is under increased scrutiny following the deaths of three patients linked to its gene therapies for muscular dystrophy. Two teenagers died after treatment with Elevidys, the...
FDA Vaccines and Drug Panels Shake Industry Norms
Recent FDA advisory committee votes have rejected Otsuka's PTSD drug Rexulti-Zoloft combination after concerns about failed Phase 3 trials and safety issues. Concurrently, a panel urged the...
Scipher Medicine Expands into Data-Driven Precision Medicine
Scipher Medicine is broadening its focus beyond diagnostics to drive precision medicine development. The company leverages the largest non-oncology clinical transcriptomic dataset, secured through...